Reported Apr 23, 2014 · Terminated
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT,…
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Rd · Cleveland, OH · 44143-2131
Is this the product you have?
- Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.
- Lot codes and dates
10 of 10 products
Products covered by this recall Model / number Product as published 728246— 728231Serial Number: 5314, 6719, 6726, 6727, 6728, 6729, 6730, 6731, 6732, 6734, 6735, 6736, 6737, 6738, 6744, 6746, 6747, 6748, 6749, 6750, 6751, 6752, 6753, 6754, 6756, 6757, 6758, 6759, 6760, 6761, 6762, 6764, 6767, 6768, 6772, and 50213. Brilliance CT 64 728243Serial Number: 10805, 10806, 90047, 95880, 95881, 95882, 95885, 95892, 95903, 95907, 95910, 95912, 95913, 95914, 95915, 95918, 95920, 95921, 95922, and 98895. Brilliance CT Big Bore Oncology 728244Serial Number: 7971, 7977, 7980, 7989, and 7994. Brilliance CT Big Bore Radiology 728306Serial Number: 7957, 7965, 7979, and 7985. Brilliance iCT 728326Serial Number: 100477, 100483, 100487, 100489, 100491, 100492, 100494, 100495, 100496, 100500, 100502, 100504, and 100507. Ingenuity CT 728321Serial Number: 300165 and 333013. Ingenuity Core 728323Serial Number: 310138, 310142, 310144, 310145, 310149, 310151, 310152, 310153, 310154, 310155, 310158, 310160, 310161, 310162, 310163, 310164, 333013, 333015, and 333017. Ingenuity Core128 728317Serial Number: 320113, 320114, 320116, 320117, 320118, 320120, 320121, 320122, 320124, 320125, 320128,320129, 320130, 320134, 320137, 320138, 320139, 320140, 320141, 320142, 320143, 320144,320145, 320146, 320147, 320148, 336009, 336010, 336011, 336012, 336013, 336015, 336016, 336018, and 336023. Ingenuity Flex — Serial Number: 345005 - Amount recalled
- 135
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Block assembly-lock stop subframe of service latch was not manufactured to engineering specifications from the supplier, causing premature fracture of the threaded rod on the patient support service latch. As a result, the table top can become free floating due to the disengaged service latch in the table tops subframe.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips Medical Systems (Cleveland) Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.